81 FR 43061 - The Food and Drug Administration's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 127 (July 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 127 (July 1, 2016)
| Page Range | 43061-43062 | |
| FR Document | 2016-15477 |
[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)] [Rules and Regulations] [Pages 43061-43062] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-15477] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2015-D-1839] The Food and Drug Administration's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a guidance for industry entitled ``FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels: Guidance for Industry.'' The guidance explains to manufacturers of conventional foods and dietary supplements our policy on determining the amount to declare on the nutrition label for certain nutrients and dietary ingredients that are present in a small amount. DATES: The guidance is available on July 1, 2016. Submit either electronic or written comments on FDA guidances at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2015-D-1839. Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of [[Page 43062]] comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the guidance to the Office of Nutrition and Food Labeling (HFS-820), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Carole Adler, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2371. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a final guidance for industry entitled ``FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels.'' We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. In the Federal Register of July 30, 2015, we made available a draft guidance for industry entitled ``FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels.'' The draft guidance would explain to manufacturers of conventional foods and dietary supplements our policy on determining the amount to declare on the nutrition label for certain nutrients and dietary ingredients that are present in a small amount. We gave interested parties an opportunity to submit comments by September 28, 2015, for us to consider before beginning work on the final version of the guidance. We received a few comments on the draft guidance, yet most pertained to the Nutrition Facts label itself or to specific nutrients rather than our policy on the declaration of small amounts. We only made editorial changes to the guidance, which include updates to the list of nutrients in 21 CFR 101.9(g)(4) and (g)(5) consistent with the final rule entitled, ``Food Labeling; Revision of the Nutrition and Supplement Facts Labels'' that appeared in the Federal Register on May 27, 2016 (81 FR 33742). The guidance announced in this document finalizes the draft guidance dated July 2015. II. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. Dated: June 24, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-15477 Filed 6-30-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations 43061
C. Impairment of hearing as described 2. Need for supplemental enteral nutrition identifies you in the body of your
under the criteria in 102.10 or 102.11. via a gastrostomy or parenteral nutrition via comments, that information will be
111.10 [Reserved] a central venous catheter. posted on http://www.regulations.gov.
111.11 [Reserved] [FR Doc. 2016–15306 Filed 6–30–16; 8:45 am] • If you want to submit a comment
111.12 Myasthenia gravis, characterized
BILLING CODE 4191–02–P with confidential information that you
by A or B despite adherence to prescribed
treatment for at least 3 months (see 111.00C): do not wish to be made available to the
A. Disorganization of motor function in public, submit the comment as a
two extremities (see 111.00D1), resulting in DEPARTMENT OF HEALTH AND written/paper submission and in the
an extreme limitation (see 111.00D2) in the HUMAN SERVICES manner detailed (see ‘‘Written/Paper
ability to stand up from a seated position, Submissions’’ and ‘‘Instructions’’).
balance while standing or walking, or use the Food and Drug Administration
upper extremities; or Written/Paper Submissions
B. Bulbar and neuromuscular dysfunction Submit written/paper submissions as
(see 111.00E), resulting in:
21 CFR Part 101
follows:
1. One myasthenic crisis requiring [Docket No. FDA–2015–D–1839] • Mail/Hand delivery/Courier (for
mechanical ventilation; or
written/paper submissions): Division of
2. Need for supplemental enteral nutrition The Food and Drug Administration’s
via a gastrostomy or parenteral nutrition via Dockets Management (HFA–305), Food
Policy on Declaring Small Amounts of and Drug Administration, 5630 Fishers
a central venous catheter. Nutrients and Dietary Ingredients on
111.13 Muscular dystrophy, characterized Lane, Rm. 1061, Rockville, MD 20852.
by disorganization of motor function in two
Nutrition Labels; Guidance for • For written/paper comments
extremities (see 111.00D1), resulting in an Industry; Availability submitted to the Division of Dockets
extreme limitation (see 111.00D2) in the AGENCY: Food and Drug Administration, Management, FDA will post your
ability to stand up from a seated position, comment, as well as any attachments,
balance while standing or walking, or use the
HHS.
except for information submitted,
upper extremities. ACTION: Notification of availability. marked and identified, as confidential,
111.14 Peripheral neuropathy, if submitted as detailed in
characterized by disorganization of motor SUMMARY: The Food and Drug
function in two extremities (see 111.00D1), Administration (FDA, we, or the ‘‘Instructions.’’
resulting in an extreme limitation (see Agency) is announcing the availability Instructions: All submissions received
111.00D2) in the ability to stand up from a of a guidance for industry entitled must include the Docket No. FDA–
seated position, balance while standing or ‘‘FDA’s Policy on Declaring Small 2015–D–1839. Received comments will
walking, or use the upper extremities. Amounts of Nutrients and Dietary be placed in the docket and, except for
111.15 [Reserved]
Ingredients on Nutrition Labels: those submitted as ‘‘Confidential
111.16 [Reserved] Submissions,’’ publicly viewable at
111.17 Neurodegenerative disorders of Guidance for Industry.’’ The guidance
explains to manufacturers of http://www.regulations.gov or at the
the central nervous system, such as Juvenile- Division of Dockets Management
onset Huntington’s disease and Friedreich’s conventional foods and dietary
supplements our policy on determining between 9 a.m. and 4 p.m., Monday
ataxia, characterized by disorganization of
motor function in two extremities (see the amount to declare on the nutrition through Friday.
111.00D1), resulting in an extreme limitation • Confidential Submissions—To
label for certain nutrients and dietary
(see 111.00D2) in the ability to stand up from submit a comment with confidential
ingredients that are present in a small
a seated position, balance while standing or information that you do not wish to be
amount.
walking, or use the upper extremities. made publicly available, submit your
111.18 Traumatic brain injury, DATES: The guidance is available on July comments only as a written/paper
characterized by disorganization of motor 1, 2016. Submit either electronic or submission. You should submit two
function in two extremities (see 111.00D1), written comments on FDA guidances at copies total. One copy will include the
resulting in an extreme limitation (see any time. information you claim to be confidential
111.00D2) in the ability to stand up from a
ADDRESSES: You may submit comments with a heading or cover note that states
seated position, balance while standing or
walking, or use the upper extremities, as follows: ‘‘THIS DOCUMENT CONTAINS
persisting for at least 3 consecutive months CONFIDENTIAL INFORMATION.’’ The
Electronic Submissions Agency will review this copy, including
after the injury.
111.19 [Reserved] Submit electronic comments in the the claimed confidential information, in
111.20 Coma or persistent vegetative following way: its consideration of comments. The
state, persisting for at least 1 month. • Federal eRulemaking Portal: http:// second copy, which will have the
111.21 Multiple sclerosis, characterized www.regulations.gov. Follow the claimed confidential information
by disorganization of motor function in two instructions for submitting comments. redacted/blacked out, will be available
extremities (see 111.00D1), resulting in an
Comments submitted electronically, for public viewing and posted on http://
extreme limitation (see 111.00D2) in the
ability to stand up from a seated position, including attachments, to http:// www.regulations.gov. Submit both
balance while standing or walking, or use the www.regulations.gov will be posted to copies to the Division of Dockets
upper extremities. the docket unchanged. Because your Management. If you do not wish your
111.22 Motor neuron disorders, comment will be made public, you are name and contact information to be
characterized by A or B: solely responsible for ensuring that your made publicly available, you can
A. Disorganization of motor function in comment does not include any provide this information on the cover
asabaliauskas on DSK3SPTVN1PROD with RULES
two extremities (see 111.00D1), resulting in confidential information that you or a sheet and not in the body of your
an extreme limitation (see 111.00D2) in the third party may not wish to be posted, comments and you must identify this
ability to stand up from a seated position,
such as medical information, your or information as ‘‘confidential.’’ Any
balance while standing or walking, or use the
upper extremities; or anyone else’s Social Security number, or information marked as ‘‘confidential’’
B. Bulbar and neuromuscular dysfunction confidential business information, such will not be disclosed except in
(see 111.00E), resulting in: as a manufacturing process. Please note accordance with 21 CFR 10.20 and other
1. Acute respiratory failure requiring that if you include your name, contact applicable disclosure law. For more
invasive mechanical ventilation; or information, or other information that information about FDA’s posting of
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![43062 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations
comments to public dockets, see 80 FR version of the guidance. We received a this interim final rule must be received
56469, September 18, 2015, or access few comments on the draft guidance, yet by August 30, 2016.
the information at: http://www.fda.gov/ most pertained to the Nutrition Facts ADDRESSES: Please send your comments
regulatoryinformation/dockets/ label itself or to specific nutrients rather on the interim final rule to one of the
default.htm. than our policy on the declaration of following addresses:
Docket: For access to the docket to small amounts. We only made editorial • http://www.regulations.gov (via the
read background documents or the changes to the guidance, which include online comment form for this document
electronic and written/paper comments updates to the list of nutrients in 21 CFR as posted within Docket No. TTB–2016–
received, go to http:// 101.9(g)(4) and (g)(5) consistent with the 0006 at Regulations.gov, the Federal e-
www.regulations.gov and insert the final rule entitled, ‘‘Food Labeling; rulemaking portal);
docket number, found in brackets in the Revision of the Nutrition and • U.S. Mail: Director, Regulations and
heading of this document, into the Supplement Facts Labels’’ that appeared Rulings Division, Alcohol and Tobacco
‘‘Search’’ box and follow the prompts in the Federal Register on May 27, 2016 Tax and Trade Bureau, 1310 G Street
and/or go to the Division of Dockets (81 FR 33742). The guidance announced NW., Box 12, Washington, DC 20005; or
Management, 5630 Fishers Lane, Rm. in this document finalizes the draft • Hand delivery/courier in lieu of
1061, Rockville, MD 20852. guidance dated July 2015. mail: Alcohol and Tobacco Tax and
Submit written requests for single Trade Bureau, 1310 G Street NW., Suite
II. Electronic Access
copies of the guidance to the Office of 400, Washington, DC 20005.
Nutrition and Food Labeling (HFS–820), Persons with access to the Internet See the Public Participation section of
Center for Food Safety and Applied may obtain the guidance at either http:// this document for specific instructions
Nutrition, Food and Drug www.fda.gov/FoodGuidances or http:// and requirements for submitting
Administration, 5100 Paint Branch www.regulations.gov. Use the FDA Web comments.
Pkwy., College Park, MD 20740. Send site listed in the previous sentence to
two self-addressed adhesive labels to find the most current version of the FOR FURTHER INFORMATION CONTACT:
assist that office in processing your guidance. Andrew L. Malone, Public Guidance
request. See the SUPPLEMENTARY Program Manager, Regulations and
Dated: June 24, 2016. Rulings Division, Alcohol and Tobacco
INFORMATION section for electronic Leslie Kux,
access to the guidance. Tax and Trade Bureau, 1310 G Street
Associate Commissioner for Policy. NW., Box 12, Washington, DC 20005;
FOR FURTHER INFORMATION CONTACT: [FR Doc. 2016–15477 Filed 6–30–16; 8:45 am] (202) 453–1039, ext. 188.
Carole Adler, Center for Food Safety and
Applied Nutrition (HFS–820), Food and
BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION:
Drug Administration, 5100 Paint Branch Background
Pkwy., College Park, MD 20740, 240–
402–2371. DEPARTMENT OF THE TREASURY Statutory Authority for Federal Civil
Monetary Penalty Inflation Adjustments
SUPPLEMENTARY INFORMATION:
Alcohol and Tobacco Tax and Trade
The Federal Civil Penalties Inflation
I. Background Bureau
Adjustment Act of 1990 (the Inflation
We are announcing the availability of 27 CFR Part 16 Adjustment Act), Public Law 101–410,
a final guidance for industry entitled 104 Stat. 890, 28 U.S.C. 2461 note,
‘‘FDA’s Policy on Declaring Small [Docket No. TTB–2016–0006; T.D. TTB–138] requires the regular adjustment and
Amounts of Nutrients and Dietary evaluation of civil monetary penalties to
RIN 1513–AC28
Ingredients on Nutrition Labels.’’ We are maintain their deterrent effect and helps
issuing this guidance consistent with Civil Monetary Penalty Inflation to ensure that penalty amounts imposed
our good guidance practices regulation Adjustment—Alcoholic Beverage by the Federal Government are properly
(21 CFR 10.115). The guidance Labeling Act accounted for and collected. A ‘‘civil
represents the current thinking of FDA monetary penalty’’ is defined in the
on this topic. It does not establish any AGENCY: Alcohol and Tobacco Tax and Inflation Adjustment Act as any penalty,
rights for any person and is not binding Trade Bureau, Treasury. fine, or other such sanction that is: (1)
on FDA or the public. You can use an ACTION: Interim final rule (Treasury For a specific monetary amount as
alternative approach if it satisfies the decision); Request for comments. provided by Federal law, or has a
requirements of the applicable statutes maximum amount provided for by
and regulations. SUMMARY: This interim final rule Federal law; (2) assessed or enforced by
In the Federal Register of July 30, implements the provisions of the an agency pursuant to Federal law; and
2015, we made available a draft Federal Civil Penalties Inflation (3) assessed or enforced pursuant to an
guidance for industry entitled ‘‘FDA’s Adjustment Act of 1990, as amended by administrative proceeding or a civil
Policy on Declaring Small Amounts of the Debt Collection Improvement Act of action in the Federal courts.
Nutrients and Dietary Ingredients on 1996 and the Federal Civil Penalties The Debt Collection Improvement Act
Nutrition Labels.’’ The draft guidance Inflation Adjustment Act Improvements of 1996 (the Improvement Act of 1996),
would explain to manufacturers of Act of 2015, with respect to the civil Public Law 104–134, section 31001(s),
conventional foods and dietary penalty provision of the Alcoholic 110 Stat. 1321, enacted on April 26,
asabaliauskas on DSK3SPTVN1PROD with RULES
supplements our policy on determining Beverage Labeling Act of 1988 (ABLA). 1996, amended the Inflation Adjustment
the amount to declare on the nutrition Specifically, this interim final rule Act by requiring civil monetary
label for certain nutrients and dietary increases the maximum civil monetary penalties to be adjusted for inflation.
ingredients that are present in a small penalty for violations of the provisions Specifically, the Improvement Act of
amount. We gave interested parties an of the ABLA from $10,000 to $19,787, 1996 required, among other things, that
opportunity to submit comments by in accordance with Federal law. the head of each Federal agency adjust
September 28, 2015, for us to consider DATES: The effective date of this interim each civil monetary penalty provided by
before beginning work on the final final rule is July 1, 2016. Comments on law within the jurisdiction of the
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Document Created: 2016-07-14 11:37:41
Document Modified: 2016-07-14 11:37:41
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Notification of availability. | |
| Dates | The guidance is available on July 1, 2016. Submit either electronic or written comments on FDA guidances at any time. | |
| Contact | Carole Adler, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2371. | |
| FR Citation | 81 FR 43061 |
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